Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Ophthalmic, as hydrochloride:
Generic: 0.05% (6 mL)
Pharmacology
Mechanism of Action
Competes with histamine for H1-receptor sites on effector cells and inhibits the release of histamine and other mediators involved in the allergic response
Pharmacokinetics/Pharmacodynamics
Absorption
Plasma concentrations following ocular administration are low for azelastine (0.02-0.25 ng/mL) and n-desmethylazelastine (0.25-0.87 ng/mL)
Onset of Action
Peak effect: 3 minutes
Duration of Action
8 hours
Use: Labeled Indications
Allergic conjunctivitis: Treatment of itching of the eye associated with allergic conjunctivitis
Contraindications
Hypersensitivity to azelastine or any component of the formulation
Dosage and Administration
Dosing: Adult
Allergic conjunctivitis: Ophthalmic: Instill 1 drop into affected eye(s) twice daily.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
Seasonal allergic conjunctivitis: Children ≥3 years and Adolescents: Ophthalmic: Instill 1 drop into affected eye(s) twice daily
Administration
For topical ophthalmic use only. Wash hands prior to use. Do not touch tip of container to any surface, the eyelids, or surrounding areas. After instilling drops, wait at least 10 minutes before inserting contact lenses. Do not insert contacts if eyes are red.
Storage
Store upright at controlled room temperature of 2°C to 25°C (36°F to 77°F).
Drug Interactions
There are no known significant interactions.
Adverse Reactions
>10%:
Central nervous system: Headache (15%)
Ocular: Transient burning/stinging (30%)
1% to 10%:
Central nervous system: Fatigue
Dermatologic: Pruritus
Gastrointestinal: Bitter taste (10%)
Ocular: Conjunctivitis, eye pain, blurred vision (temporary)
Respiratory: Asthma, dyspnea, pharyngitis, rhinitis
Miscellaneous: Flu-like syndrome
Warnings/Precautions
Dosage form specific issues:
- Solution contains benzalkonium chloride; remove lens prior to administration and wait at least 10 minutes before reinserting. Do not use contact lenses if eyes are red.
Pregnancy
Pregnancy Risk Factor
C
Pregnancy Considerations
Animal reproduction studies have shown toxic effects to the fetus at maternally toxic doses.
Patient Education
What is this drug used for?
- It is used to ease allergy signs in the eye.
Frequently reported side effects of this drug
- Headache
- Burning
- Stinging
- Bad taste
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- Vision changes
- Eye pain
- Severe eye irritation
- Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
